1. Field of the Invention
This invention relates to anastomotic implants. More particularly, the invention is directed for use in effecting an end to side anastomotic juncture.
2. State of the Art
An objective of vascular reconstructive surgery is the reconstitution of blood flow from a blood vessel which has ceased effective operation. The necessity of grafting a replacement vessel to the sidewall of the damaged blood vessel arises with significant frequency. Cardiovascular disease is the current paramount cause of natural deaths in the U.S. Approximately 485,000 coronary bypass procedures requiring vascular anastomosis performed annually plus one million other vascular surgeries requiring vascular anastomosis (ex. shuts, fistular, fem-fem bypass) are performed annually in the U.S. Of the aforesaid 485,000 bypass procedures each bypass procedure requires on average between 2-5 anastomosis procedures to be effected. It follows effectively that end-to-side anastomosis techniques and implants are of critical importance in the medical community. As used herein, "end-to-side" is independent of blood flow direction and, therefore, "end-to-side anastomsis" includes an end-to-side anastomsis as well as a side-to-end anastomosis. Vascular grafts may be formed from autogenous blood vessels harvested from other locations in the patient's body or alternatively may be manufactured from synthetic or non autogenous vessels.
Coronary bypass surgery is the commonly-adopted treatment for coronary ischemic (heart attacks). This surgery is time consuming and requires an inventory of skilled techniques. The general procedure may require between four to six hours and is typically accompanied by the surgeon's stopping the patient's heart in order to facilitate delicate suturing of vascular tissue. The success of such procedures is heavily dependent on the individual skills of the participating surgeons. Vascular anastomosis forms an essential component in a typical coronary bypass procedure.
An anastomosis typically includes a manually sutured junction of the graft vessel with the effected vascular vessel. Understandably, as the size, e.g. diameter, of the involved vessels decrease in size the ability of the surgeon to effect a suture having long-term viability is severely challenged.
The time consumed in suturing the vessels in a bypass procedure can easily exceed fifty percent (50%) of the time involved in the procedure. It follows that any procedure or apparatus which would decrease the time commitment necessitated by suturing holds potential in this environment. Furthermore, significant reduction in the time involved in effecting the anastomosis itself could potentially lead to the elimination of the need for cardiopulmonary bypass, which, in and of itself, would be a considerable step forward in lessening the risk associated with this type of procedure.
Of considerable concern in bypass procedures is the potentiality of vascular graft failure. A principal cause of such failure is turbulent blood flow over a rough suture line. Other concerns include the quality of the involved graft vessel, a potential mismatch in the diameter of the treated vessel and the graft, and an improper angle of bifurcation at the anastomosis juncture.